Associate Principal Scientist, Mixed Modality Product Development
About The Position
The Mixed Modalities team within Sterile Product Development develops parenteral dosage forms—including injections, implants, inhaled products, and ocular products—for small, intermediate, and large molecules, from preclinical toxicology studies through commercialization. The team uses fundamental understanding and characterization, experimental design, analytical tools, and predictive approaches to select robust compositions, primary packaging and devices, and scalable processes while preserving product stability, safety, efficacy, and delivery. The Associate Principal Scientist develops parenteral drug products across modalities including small molecules, peptides, proteins, antibody-drug conjugates, and other biologics. The role supports early- and late-stage development, provides strategic and technical leadership on program teams, and collaborates with stakeholders across functions and external manufacturing sites. The position also contributes to organizational innovation, technical knowledge-sharing, mentoring, and professional activities such as patents, presentations, and publications.
Requirements
- Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or a related discipline, with at least 4–5 years of relevant industry experience; or a B.S. or M.S. in Engineering, Pharmaceutical Sciences, or a related discipline, with at least 8 years of relevant industrial experience.
- Experience in biologics process development and characterization, particularly for late-stage programs.
- Ability to lead formulation development in matrix team environments and define robust formulations and manufacturing processes.
- Recognized technical expert and scientific contributor with a demonstrated ability to identify and develop innovative ideas.
- Broad knowledge of formulation science, in-depth knowledge in multiple areas, and a core understanding of the drug development process.
- Track record of working effectively with team members from diverse backgrounds and skill sets.
- Strong verbal and written communication skills.
- Strong track record in product development, regulatory filings, drug delivery, or complex formulation and process development and characterization, reflected through industry experience and external publications or patents.
- Initiative, motivation to excel, strong technical background, excellent interpersonal skills, ability to multitask, and desire to learn and contribute.
- Required skills include biologics, cell line development, design of experiments, downstream process development, drug delivery, drug product development, expression vectors, molecular biology, particle engineering, pharmaceutical formulations, pharmaceutical process development, product formulation, technology transfer, and toxicology.
Nice To Haves
- Deep understanding of one or more of surface science, colloid science, particle engineering, antibody-drug conjugates, or high-concentration formulations.
- Prior experience leading development projects at an enterprise level.
- Ability to mentor peers and serve as a technical mentor.
- Recognition as a subject matter expert in at least one drug delivery or manufacturing technology.
- Demonstrated ability to identify, fundamentally characterize, and address manufacturing challenges through development and optimization of novel production technologies.
- Desire to build new capabilities by evaluating new technologies and hands-on optimization of existing technologies.
- Prior experience with process scale-up, modeling, regulatory filings, or driving key capability evaluation or development.
Responsibilities
- Lead or contribute to innovative approaches for biologics sterile product development by generating experimental designs, executing experimental plans, and analyzing data.
- Support early- and late-stage development candidates, including screening and developing robust drug product compositions and scalable processes.
- Develop primary packaging and characterize compatibility for processing and administration; support regulatory filings.
- Build fundamental knowledge of drug products and ensure completion of key milestones and laboratory and regulatory documentation.
- Provide strategic and technical leadership on program development teams, interface with stakeholders, and collaborate across functions to achieve milestones.
- Lead and champion organizational strategic and innovation objectives aligned with organizational goals.
- Mentor scientists and contribute technical expertise in a multidisciplinary team environment.
- Lead project activities at external manufacturing sites, including technology transfers.
- Advance the company's professional image and competitive advantage through patents, presentations, publications, and professional activities.
- Advance science and technology development, technical and business strategic improvements, and business process innovations.
- Maintain awareness of relevant current and emerging technologies and capabilities, and share knowledge with others.
Benefits
- Medical, dental, and vision healthcare benefits for employees and family
- Other insurance benefits for employees and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Annual bonus eligibility
- Long-term incentive eligibility, if applicable
- Domestic relocation
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What This Job Offers
Job Type
Full-time
Career Level
Senior
